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Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke (AHSCTIS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Yaguo Li, Zhejiang Hospital.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Zhejiang University
Information provided by (Responsible Party):
Yaguo Li, Zhejiang Hospital
ClinicalTrials.gov Identifier:
NCT01518231
First received: January 10, 2012
Last updated: January 24, 2012
Last verified: January 2012
January 10, 2012
January 24, 2012
January 2012
December 2012   (Final data collection date for primary outcome measure)
Change from Baseline in NIH-stroke scale (NIHSS) at 12 months [ Time Frame: 1,3,6,12 months after cell transplantation ]
Same as current
No Changes Posted
  • Barthel index [ Time Frame: 1,3,6,12 months after cell transplantation ]
  • perfusion magnetic resonance imaging scan [ Time Frame: 1,3,6,12 months after cell transplantation ]
  • Modified Rankin Scale(mRS) [ Time Frame: 3,6,12 months after cell transplantation ]
Same as current
Not Provided
Not Provided
 
Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke
Phase 1 Study of Autologous Peripheral Hematopoietic Stem Cell Transplantation in Ischemic Stroke
The purpose of this study is to evaluate the safety and efficacy of autologous peripheral hematopoietic stem cell transplantation in ischemic stroke.
Stroke is among the main causes of mortality and disability of elderly population which still lack of efficient therapy. Stem sell transplantation provides a functional improvement after cerebral ischemia in rat models. Our study will recruit 40 ischemic stroke patients which will be divided into 2 groups (20 patients each): treatment group and control group. The former will be implanted with peripheral blood stem cell through anterior cerebral artery or middle cerebral artery (determined by the section of infarction) and receive convention stroke therapy. The latter only receive convention stroke therapy. The investigators expect that transplantation of the peripheral hematopoietic stem cell is safe and efficient to neurological recovery.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Stroke
  • Procedure: autologous hematopoiesis stem cell transplantation
    Every participant will be transplanted with about 4 million autologous peripheral blood stem cell(CD34+) through cerebral artery.
  • Drug: Aspirin
    aspirin 100mg,qd,po(patients with no fibrillation atrial)
  • Drug: Warfarin
    warfarin 2~6mg,qd,po(patients with fibrillation atrial);
  • Drug: Atorvastatin
    atorvastatin 20mg,qd,po
  • Drug: Edaravone
    edaravone 30mg,bid,ivgtt.
  • Drug: Warfarin
    warfarin 2~6mg,qd,po(patients with fibrillation atrial)
  • Drug: Edaravone
    edaravone 30mg,bid,ivgtt
  • Experimental: cell transplantation
    The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
    Interventions:
    • Procedure: autologous hematopoiesis stem cell transplantation
    • Drug: Aspirin
    • Drug: Warfarin
    • Drug: Atorvastatin
    • Drug: Edaravone
  • No Intervention: Convention therapy
    The control group just receive drug therapy.
    Interventions:
    • Drug: Aspirin
    • Drug: Warfarin
    • Drug: Atorvastatin
    • Drug: Edaravone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
December 2013
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • aged 40~70
  • no consciousness disorders
  • internal carotid artery territory infarction
  • stroke happened < 1 year
  • with stable hemiplegia, but remain dependent in daily life
  • SSS(Scandinavian Stroke Scale) < 40

Exclusion Criteria:

  • pregnant women
  • can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition
Sexes Eligible for Study: All
40 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01518231
Zhejiang Hospital
No
Not Provided
Not Provided
Yaguo Li, Zhejiang Hospital
Zhejiang Hospital
Zhejiang University
Study Director: Yaguo Li, master Zhejiang Hospital
Principal Investigator: Yumiao Zhou, master Zhejiang Hospital
Zhejiang Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP